Benzyl Alcohol is a liquid and Benzoic Acid is a white, crystalline powder. Sodium Benzoate is the sodium salt of Benzoic Acid. In cosmetics and personal care products, Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate are used in the formulation of a wide variety of product types.
The Food and Drug Administration (FDA) includes Benzoic Acid and Sodium Benzoate on its list of direct food substances affirmed as Generally Recognized As Safe (GRAS). Benzyl Alcohol is also approved as a synthetic flavoring agent for direct addition to food. Benzyl Alcohol is approved as an anesthetic ingredient in Over-the-Counter (OTC) anorectal, oral healthcare and topical analgesic drug products.
The safety of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Benzyl Alcohol, Benzoic Acid and Sodium Benzoate were safe for use in cosmetics and personal care products at concentrations up to 5%. The available data were insufficient to support the safety of these ingredients in cosmetics and personal care products in which a primary route of exposure is inhalation. The CIR Expert Panel also concluded that Benzyl Alcohol was safe for use in hair dyes at concentrations up to 10%.CIR Safety Review: The CIR Expert Panel noted that no adverse effects of Benzyl Alcohol were seen in chronic oral exposure studies. Effects of Benzoic Acid and Sodium Benzoate in chronic oral exposure studies were limited to reduced feed intake and reduced growth. At doses used in cosmetics and personal care products, the CIR Expert Panel was not concerned about potential reproductive and developmental effects. Although, genotoxicity tests for these ingredients were mostly negative, there were some assays that were positive. Carcinogenicity studies, however, were negative.
Clinical data indicated that in a few individuals these ingredients produced non-immunologic contact urticaria and non-immunologic immediate contact reactions, characterized by the appearance of wheals, erythema, and pruritis. In one study, 5% Benzyl Alcohol elicited a reaction, and in another study, 2% Benzoic Acid did likewise. Benzyl Alcohol, however, was not a sensitizer at 10%, nor was Benzoic Acid a sensitizer at 2%. Recognizing that the non-immunologic reactions were strictly cutaneous, likely involve a cholinergic mechanism, it was concluded that these ingredients could be used safely at concentrations up to 5%. Additionally, Benzyl Alcohol was considered safe at up to 10% for use in hair dyes. The limited body exposure, the duration of use, and the frequency of use were considered in concluding that the non-immunologic reactions would not be a concern.
The CIR Expert Panel concluded that inhalation toxicity data were needed to complete the safety assessment of these ingredients for use in products where inhalation can occur, such as aerosols.
Link to FDA Code of Federal Regulations and the Federal Register for Benzoic Acid, Sodium Benzoate, and Benzyl Alcohol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.fda.gov/cder/otcmonographs/Oral_Health_Care/oral_...
http://www.fda.gov/cder/otcmonographs/External_Analgesic/ext...
Benzyl Alcohol may be used as a preservative in cosmetics and personal care products marketed in the European Union at a maximum concentration of 1%. Benzoic Acid and its salts and esters are also permitted for use as preservatives in cosmetics and personal care products at a maximum concentration (expressed as the acid) of 2.5% in rinse-off products (except oral care products), 1.7% in oral care products and 0.5% in leave on products (see Annex VI).
Benzyl Alcohol is also listed in in Annex III of the European Union Cosmetics Directive. Its use is restricted to solvents, perfumes and flavorings. When Benzyl Alcohol is used as a fragrance ingredient, Annex III requires that the presence of this fragrance ingredient be indicated on the label of the product, and its use is limited to 0.001% in leave-on products, and 0.01% in rinse-off products.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-5 mg/kg for the sum of Benzoic Acid, Potassium and Sodium Benzoate.
http://www.inchem.org/documents/jecfa/jecmono/40abcj02.htm
